MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number FG540000

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent a procedure for atrioventricular nodal reentrant tachycardia (avnrt) with a carto 3 system where a map shift occurred.During the case, after the electrophysiology study but prior to starting ablation, a map shift of approximately two centimeters was noticed on the carto 3 system.No error messages populated.There was no apparent patient movement, no cardioversion performed, and the reference patches had not moved.A new map was created to complete the case, which ended without patient consequence.It was noted that fluoroscopy was not used during the case.

Manufacturer Narrative

It was reported that a patient underwent a procedure for atrioventricular nodal reentrant tachycardia (avnrt) with a carto 3 system where a map shift occurred.During the case, after the electrophysiology study but prior to starting ablation, a map shift of approximately two centimeters was noticed on the carto 3 system.No error messages populated.There was no apparent patient movement, no cardioversion performed, and the reference patches had not moved.A new map was created to complete the case, which ended without patient consequence.It was noted that fluoroscopy was not used during the case.The issue is related to user error.The biosense webster inc.(bwi) field representative reported that the stx magnets were brought in and they were not in place when the system was initialized.The bwi field service engineer (fse) advised on correct workflow and explained on how the environment around the patient table should be prepared and maintained for the entirety of the case before initializing the carto 3 system.The bwi field representative confirmed that during next case, no issues were observed and the system is fully functional when a proper workflow is followed for initializing the system.Device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Date of event corrected from (b)(6) 2017 to (b)(6) 2017.(b)(4).

• Brand Name: CARTO 3
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: evgeniya degnera ; 33 technology drive; irvine, CA 92618 ; 626257-919
• MDR Report Key: 6922294
• MDR Text Key: 89937814
• Report Number: 3008203003-2017-01011
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1